Comparison of Patient Centered Outcomes for People With SCD in the Acute Care Setting (ESCAPED)
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|ClinicalTrials.gov Identifier: NCT02411396|
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : December 5, 2018
The Emergency Department has been the standard location where patients with Sickle Cell Disease (SCD) go to seek care for the treatment of acute painful events. Vaso- Occlusive Crisis (VOC) is the most common complication of SCD,
The purpose of this study is to compare patient centered outcomes for patients being treated for an uncomplicated VOC in Infusion Centers (IC) and Emergency Departments (ED) in four locations around the United States.
|Condition or disease||Intervention/treatment|
|Sickle Cell Disease||Other: Patient Centered Outcomes|
Emergency Department care is marked by long delays, lack of efficacy, and conflict. A sub-specialty Infusion Center staffed by expert clinicians and delivering individualized care can improve care quality while reducing costs. The study will examine whether care provided in an Infusion Center is more patient centered and efficient than care provided in an Emergency Department for adults with SCD and uncomplicated VOC.
Sites will prospectively enroll patients in VOC seen in participating centers from either the EDs or the ICs. Specific data from the acute visits (e.g. Times of arrival, time to first dose of analgesic, etc) will be captured. This study will compare: pain management, disposition of subjects (home or admission) and patient experiences of care delivery in both settings. Subjects will complete surveys/questionnaires to asses their experiences in the setting where care was provided.
The four sites to participate in the study are Baltimore, Maryland (Johns Hopkins Hospital), Cleveland, Ohio (Cleveland Medical Center), Milwaukee, Wisconsin (Medical College of Wisconsin), and Baton Rouge, Louisiana (Our Lady of the Lake Hospital). A maximum of 500 subjects will participate in the study. Participants will be enrolled for 18 months.
|Study Type :||Observational|
|Actual Enrollment :||483 participants|
|Official Title:||Patient Centered Outcomes Research Institute (PCORI) ESCAPED Study: Comparison of Patient Centered Outcomes for People With SCD in the Acute Care Setting|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||June 2018|
|Actual Study Completion Date :||June 2018|
VOC in patients with SCD
This is an observational study comparing patient centered outcomes for patients treated for uncomplicated VOC in ICs and EDs.
Other: Patient Centered Outcomes
Comparison of treatment in patients with SCD in VOC in acute care settings
- Time from arrival to center to time first dose of parenteral pain medication administered [ Time Frame: Within 6 hours after arrival ]Comparing time to medicate in the ED versus the Infusion Center
- Outcome of acute visit [ Time Frame: Day 1 ]Admission, emergency department or discharge to home
- Pain level after first dose of pain medication administered [ Time Frame: 30 minutes after administration ]The pain level of patient will be assessed on a pain score survey tool administered after the first dose
- Patient reported satisfaction [ Time Frame: within 72 hours of acute visit ]Survey to capture patient comments on treatment received in facility
- Patient reported perceptions of risk from visit [ Time Frame: within 72 hours of acute visit ]Survey to capture patient concerns for safety while present in facility
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02411396
|United States, Louisiana|
|Our Lady of the Lake Hospital|
|Baton Rouge, Louisiana, United States, 70809|
|United States, Ohio|
|Cleveland Medical Center at University Hospitals|
|Cleveland, Ohio, United States, 44106|
|United States, Wisconsin|
|Medical College of Wisconsin, Blood Center|
|Milwaukee, Wisconsin, United States, 53201|
|Principal Investigator:||Sophie Lanzkron, MD, MHS||Johns Hopkins University, Division of Hematology|